GUEST COLUMNISTS

  • Applying Lean Thinking To Support Processes in MedTech, Biotech Organizations
    Applying Lean Thinking To Support Processes in MedTech, Biotech Organizations

    This article answers the question, “how can lean thinking be applied to areas like QARs, QC tests, and document control procedures to remove waste while still adhering to regulations?”

  • Why Aren’t More CDMOs Using Continuous Manufacturing For API Production?
    Why Aren’t More CDMOs Using Continuous Manufacturing For API Production?

    This is the first of a two-part article exploring the factors creating a demand from innovator biopharmaceutical companies for continuous manufacturing facilities in the U.S. and EU. It also covers the economic and technical challenges facing CDMOs considering building API CM facilities.

  • Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook
    Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but whether it is implemented and becomes an effective measure to sustain the biosimilar market is yet to be determined.

  • Market Assessment: Transcatheter Aortic Valve Replacement In The U.S. and EU
    Market Assessment: Transcatheter Aortic Valve Replacement In The U.S. and EU

    It’s an exciting time for TAVR, as the market has experienced exponential growth due to expanding indications of TAVR devices in recent years. So, what are this market’s long- and short-term projections, and what barriers exist to more widespread use?

  • FDA FY2018 Drug Inspection Observations And Trends
    FDA FY2018 Drug Inspection Observations And Trends

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  • Developing Novel Policy Proposals To Support Access To Gene And Cell Therapies
    Developing Novel Policy Proposals To Support Access To Gene And Cell Therapies

    The decades-long focus on more “personalized” medicines has paved the way for the recent and anticipated advances in gene and cell therapies and progress in many other areas. The first generation of gene and cell therapies has the potential to transform the way we treat some diseases and can bring new hope to patients with many rare and serious conditions.

  • Comparing New U.S. & EU Guidances On The Combination Product Approval Process
    Comparing New U.S. & EU Guidances On The Combination Product Approval Process

    The new EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts by each regulatory body to adequately regulate combination products. In Part 2 of this two-part series, we cover the European Union guidelines for combination products and show how the U.S. and the EU diverge.

  • What Will Clinical Trials Look Like In 10 Years? Experts Forecast 3 Key Trends
    What Will Clinical Trials Look Like In 10 Years? Experts Forecast 3 Key Trends

    Clinical research has benefited from several advancements in recent decades. Expanding access to information has empowered patients to have greater autonomy in their care and a voice during the development process. Personalized medicine has given rise to promising new therapies treating smaller, more targeted populations. And the number of clinical trials leveraging virtual health tools and mobile technology is increasing. But seismic challenges still remain.

More From Guest Columnists

PHARMA OUTSOURCING WHITE PAPERS

  • Understand Your Process: A Key To CMO Risk Mitigation
    Understand Your Process: A Key To CMO Risk Mitigation

    The advantages of contract manufacturing come with certain practical risks. Many of those risks are associated with inadequate communication and knowledge transfer between the drug’s originator and the CMO. Throughout this paper on CMO risk mitigation, we will approach the subject from the perspective of a sterile drug product CMO and establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.

More Pharma Outsourcing White Papers
Louis2019

OUTSOURCED PHARMA CONTENT COLLECTIONS

OP_CDMOGlobalIndustryEbook_300x200

 

Are we dangerously reliant on outsourcing to China, and is this outsourcing without the good of U.S. patients in mind? Our drug development and manufacturing outsourcing industry can’t escape the ins-and-outs of geopolitical and global affairs. Learn more in this free collection of articles

More Content Collections

OUTSOURCING EVENTS

CRO Oversight Post ICH GCP E6 (R2) Addendum October 22 - 22, 2019
1pm-2:00pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Writing Effective 483 and Warning Letter Responses October 23 - 23, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Cleanroom Microbiology – A Foundational Introduction November 5 - 5, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance November 6 - 6, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
20th Annual Pharma Middle East Congress November 11 - 12, 2019
Istanbul, ID
More Industry Events